Positive Phase III ECHO Trial Results Offer New Treatment Option for Patients Aged 65+ with Untreated Mantle Cell Lymphoma

China Finance Network June 20th — The positive results of the Phase III ECHO trial indicate that AstraZeneca's Calquence (generic name: acalabrutinib capsules) in combination with bendamustine and rituximab demonstrated a statistically and clinically significant improvement in progression-free survival (PFS) among previously untreated mantle cell lymphoma (MCL) patients, with overall survival (OS) showing a favorable trend compared to the standard immunochemotherapy regimen (bendamustine plus rituximab).

These results were recently announced in an oral presentation as a breakthrough research at the European Hematology Association (EHA) 2024 Hybrid Congress held in Madrid, Spain (#LBA3439).

The results showed that, compared with the standard immunochemotherapy regimen, the combination therapy with acalabrutinib reduced the risk of disease progression or death by 27% (hazard ratio [HR] 0.73; 95% confidence interval [CI] 0.57-0.94; p=0.016). The median PFS for the acalabrutinib combination therapy was 66.4 months (n=299), compared to 49.6 months (n=299) for the standard immunochemotherapy regimen.

Compared with the standard immunochemotherapy regimen, the secondary endpoint OS showed a trend of benefit with acalabrutinib combination therapy, further supporting the clinical benefit of this combination therapy. At the time of this analysis, the OS data were not yet mature, and the trial will continue to evaluate OS as a key secondary endpoint.

The ECHO clinical trial enrolled participants during the COVID-19 pandemic and conducted a pre-specified censoring analysis for COVID-related deaths to assess their impact. Both groups showed improvements in PFS, with the acalabrutinib combination therapy reducing the risk of disease progression or death by 36% (HR 0.64; 95% CI; 0.48-0.84; p=0.0017). The median PFS for patients receiving acalabrutinib combination therapy was not reached, while the median PFS for those receiving standard immunochemotherapy was 61.6 months (HR 0.64, 95% CI, 0.48-0.84; p=0.0017). In the analysis of acalabrutinib combination therapy, OS showed a trend toward benefit (HR 0.75; 95% CI 0.53-1.04; p=0.0797).

Michael Wang, MD, Puddin Clarke Distinguished Professor, Director of the Mantle Cell Lymphoma Excellence Program, and Co-Director of Clinical Trials at MD Anderson Cancer Center in Houston, Texas, and principal investigator of the ECHO study, stated that for patients with mantle cell lymphoma, a typically aggressive subtype of non-Hodgkin lymphoma, the results of the ECHO trial offer a new and effective treatment option for adults over 65, a group that represents the majority of mantle cell lymphoma patients. "Compared to standard immunochemotherapy, the acalabrutinib combination therapy demonstrated improved progression-free survival and is the only BTK inhibitor proven to have the potential as a first-line standard treatment for mantle cell lymphoma."

Susan Galbraith, Executive Vice President of AstraZeneca and Head of Oncology R&D, stated that the ECHO trial data demonstrated significant progress in improving outcomes for patients with mantle cell lymphoma. The ability of patients to survive an additional 16.8 months without disease progression, along with a favorable trend in overall survival, holds substantial clinical significance. "Therefore, we believe that acalabrutinib combined with immunochemotherapy will become an important new option for patients suffering from this disease."